FDA Labels API

Retrieve FDA drug label (package insert) content.

Overview

The FDA Labels API provides access to structured drug label content from FDA DailyMed. Labels include prescribing information, warnings, dosing instructions, and more.

Endpoints

Method	Path	Description
GET	`/v1/fda-label/:identifier`	Get label by NDC, RxCUI, or Set ID
GET	`/v1/fda-label/:identifier/sections/:bundle`	Get specific section bundle
POST	`/v1/fda-label/_batch`	Batch lookup (up to 50)
GET	`/v1/fda-label/sections-info`	List available sections and bundles

Lookup by Identifier

You can look up labels using:

NDC: 0069-0151-01
RxCUI: 197361
Set ID: a1b2c3d4-e5f6-... (UUID)

curl -X GET "https://api.fhirfly.io/v1/fda-label/0069-0151-01" \
  -H "x-api-key: YOUR_API_KEY"

Section Bundles

Request specific sections using the bundle parameter:

Bundle	Sections Included
`safety`	Warnings, contraindications, adverse reactions
`dosing`	Dosage, administration, how supplied
`interactions`	Drug interactions, clinical pharmacology
`pregnancy`	Pregnancy, lactation, pediatric/geriatric use
`ingredients`	Active/inactive ingredients, description

# Get only safety-related sections
curl -X GET "https://api.fhirfly.io/v1/fda-label/0069-0151-01?bundle=safety" \
  -H "x-api-key: YOUR_API_KEY"

Response

{
  "data": {
    "set_id": "a1234567-b890-c123-d456-e78901234567",
    "version": "15",
    "effective_date": "2023-06-15",
    "product_name": "Lipitor",
    "sections": {
      "warnings_and_precautions": {
        "title": "WARNINGS AND PRECAUTIONS",
        "text": "..."
      },
      "contraindications": {
        "title": "CONTRAINDICATIONS",
        "text": "..."
      }
    }
  },
  "meta": {
    "legal": {
      "license": "public_domain",
      "citation": "FDA DailyMed"
    }
  }
}

Individual Sections

Request specific sections with the sections parameter:

curl -X GET "https://api.fhirfly.io/v1/fda-label/0069-0151-01?sections=boxed_warning,contraindications" \
  -H "x-api-key: YOUR_API_KEY"

Metadata Only

Get label metadata without section content:

curl -X GET "https://api.fhirfly.io/v1/fda-label/0069-0151-01?meta=true" \
  -H "x-api-key: YOUR_API_KEY"

Required Scope

fda.read - Label lookups
fda.batch - Batch lookups